The goal of this validation study is to evaluate the efficacy of the new at-home test for diagnosing COVID-19. Mailing simple testing kits directly to patients could help reduce visits to overwhelmed clinics and hospitals, ease traffic at drive-through testing sites, and enhance social distancing efforts.
"While everyone wants more COVID-19 tests, what will really multiply the impact is having a more convenient high-quality test that preserves social distancing, which will better protect patients and healthcare providers alike," said Ahmad Namvargolian, CEO and co-founder of Care Access Research.
Care Access Research will lead the validation study at several of its clinical research sites across the U.S. Expected to be completed within weeks, the clinical trial will need between 60 and 500 patient volunteers to determine the test’s accuracy at diagnosing the COVID-19 disease caused by the pandemic novel coronavirus (SARS-CoV-2) sweeping the globe.
"Reliability and safety come first, which is why it’s so important to complete a validation study of the new at-home COVID-19 test as soon as possible," said Namvargolian. "Care Access Research is able to respond quickly because we manage so many research sites with superior standard operating procedures, good clinical practices and centralized support teams, all with a proven record of connecting volunteers to clinical trials and completing high-quality studies fast."
If approved by the FDA, the new COVID-19 test will offer similar conveniences to the private lab’s currently available at-home genetic test kits that screen DNA for a variety of medical conditions. Patients order kits, take a personal biomedical sample at home, ship their sample to the lab for analysis and get test results in a timely manner.